Module 18 - Drug Device Combinations and Other Technologies

05/12/2023

Drug/device evaluation Some considerations ….

• Are the constituent parts already approved for an indication?

• Does the combination product expose the patient to a new route of administration or a new local or systemic exposure profile for an existing indication? • Is the drug formulation different to that used in the already approved drug? • Are the device and drug constituents chemically, physically, or otherwise combined into a single entity?

• Is the combination intended to treat a different patient population?

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Preamble

Toxicological hazard • Nature of toxic effects • Dosages at which they occur • The No Observed Adverse Effect Level (NOAEL)

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Toxicological risk • Quantitative assessment of nature of effects in context of amount to which subject is exposed and route of exposure

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The Organisation for Professionals in Regulatory Affairs

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